Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS)
People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual's memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope wi...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2015-12, Vol.16 (1), p.556-556, Article 556 |
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| creator | Lincoln, Nadina B das Nair, Roshan Bradshaw, Lucy Constantinescu, Cris S Drummond, Avril E R Erven, Alexandra Evans, Amy L Fitzsimmons, Deborah Montgomery, Alan A Morgan, Miriam |
| description | People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual's memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope with these problems, in order to reduce the impact on everyday life. The effectiveness of cognitive rehabilitation for people with multiple sclerosis has not been established.
This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems. All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological subscale at 12 months will be used to estimate the effect of the group cognitive rehabilitation programme.
The study will provide evidence regarding the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems in people with multiple sclerosis.
ISRCTN09697576 . Registered 14 August 2014. |
| doi_str_mv | 10.1186/s13063-015-1016-3 |
| format | Article |
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This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems. All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological subscale at 12 months will be used to estimate the effect of the group cognitive rehabilitation programme.
The study will provide evidence regarding the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems in people with multiple sclerosis.
ISRCTN09697576 . Registered 14 August 2014.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-015-1016-3</identifier><identifier>PMID: 26643818</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Activities of Daily Living ; Adolescent ; Adult ; Aged ; Analysis ; Attention ; Clinical Protocols ; Cognition ; Cognitive Behavioral Therapy - economics ; Cognitive Behavioral Therapy - methods ; Cost analysis ; Cost control ; Cost-Benefit Analysis ; Employment ; Female ; Health aspects ; Health Care Costs ; Health surveys ; Humans ; Informed consent ; Intention to Treat Analysis ; Intervention ; Male ; Memory ; Middle Aged ; Multiple sclerosis ; Multiple Sclerosis - diagnosis ; Multiple Sclerosis - economics ; Multiple Sclerosis - psychology ; Multiple Sclerosis - rehabilitation ; Neuropsychology ; Psychiatric Status Rating Scales ; Psychologists ; Psychotherapy, Group - economics ; Psychotherapy, Group - methods ; Quality of Life ; Questionnaires ; Regression Analysis ; Rehabilitation ; Research Design ; Social services ; Study Protocol ; Surveys and Questionnaires ; Time Factors ; Treatment Outcome ; United Kingdom ; Young Adult</subject><ispartof>Current controlled trials in cardiovascular medicine, 2015-12, Vol.16 (1), p.556-556, Article 556</ispartof><rights>COPYRIGHT 2015 BioMed Central Ltd.</rights><rights>Lincoln et al. 2015. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Lincoln et al. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c564t-d26796fadc540fc3ab6f8b70a030b8ec66af0d3be8651b99b9209811f96fe9233</citedby><cites>FETCH-LOGICAL-c564t-d26796fadc540fc3ab6f8b70a030b8ec66af0d3be8651b99b9209811f96fe9233</cites><orcidid>0000-0001-5604-2339</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4672565/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4672565/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26643818$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lincoln, Nadina B</creatorcontrib><creatorcontrib>das Nair, Roshan</creatorcontrib><creatorcontrib>Bradshaw, Lucy</creatorcontrib><creatorcontrib>Constantinescu, Cris S</creatorcontrib><creatorcontrib>Drummond, Avril E R</creatorcontrib><creatorcontrib>Erven, Alexandra</creatorcontrib><creatorcontrib>Evans, Amy L</creatorcontrib><creatorcontrib>Fitzsimmons, Deborah</creatorcontrib><creatorcontrib>Montgomery, Alan A</creatorcontrib><creatorcontrib>Morgan, Miriam</creatorcontrib><title>Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS)</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>Trials</addtitle><description>People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual's memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope with these problems, in order to reduce the impact on everyday life. The effectiveness of cognitive rehabilitation for people with multiple sclerosis has not been established.
This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems. All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological subscale at 12 months will be used to estimate the effect of the group cognitive rehabilitation programme.
The study will provide evidence regarding the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems in people with multiple sclerosis.
ISRCTN09697576 . Registered 14 August 2014.</description><subject>Activities of Daily Living</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Analysis</subject><subject>Attention</subject><subject>Clinical Protocols</subject><subject>Cognition</subject><subject>Cognitive Behavioral Therapy - economics</subject><subject>Cognitive Behavioral Therapy - methods</subject><subject>Cost analysis</subject><subject>Cost control</subject><subject>Cost-Benefit Analysis</subject><subject>Employment</subject><subject>Female</subject><subject>Health aspects</subject><subject>Health Care Costs</subject><subject>Health surveys</subject><subject>Humans</subject><subject>Informed consent</subject><subject>Intention to Treat Analysis</subject><subject>Intervention</subject><subject>Male</subject><subject>Memory</subject><subject>Middle Aged</subject><subject>Multiple sclerosis</subject><subject>Multiple Sclerosis - diagnosis</subject><subject>Multiple Sclerosis - economics</subject><subject>Multiple Sclerosis - psychology</subject><subject>Multiple Sclerosis - rehabilitation</subject><subject>Neuropsychology</subject><subject>Psychiatric Status Rating Scales</subject><subject>Psychologists</subject><subject>Psychotherapy, Group - economics</subject><subject>Psychotherapy, Group - methods</subject><subject>Quality of Life</subject><subject>Questionnaires</subject><subject>Regression Analysis</subject><subject>Rehabilitation</subject><subject>Research Design</subject><subject>Social services</subject><subject>Study Protocol</subject><subject>Surveys and Questionnaires</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>United Kingdom</subject><subject>Young Adult</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNptUt1uFCEYJUZj29UH8MaQeNNeTIVhYAYvTDYb_5JuTFq9JgwDuzQMrMDU7Ev4zDLdWltjuIAPvnPgHA4ArzA6x7hjbxMmiJEKYVphhFlFnoBj3Da0YjWmTx-sj8BJStcINYST5jk4qhlrSIe7Y_BrFTbeZnuj4aXeyt46m2W2wUMTIlzmrP1tJf0A13oMcQ-thzsddk7DnzZv4Xpy2c7VlXI6hmTTO5jyNOzhLoYcVHC3VBLGwhFGm_QAVfA5BufKMkcrHTxdXS7X66uzF-CZkS7pl3fzAnz_-OHb6nN18fXTl9XyolKUNbkaatZyZuSgaIOMIrJnputbJBFBfacVY9KggfS6YxT3nPe8RrzD2BSQ5jUhC_D-wLub-lEPqqiM0oldtKOMexGkFY9PvN2KTbgRDWtrymghOL0jiOHHpFMWRZnSzkmvw5REsb4lNSe0K61v_mm9DlP0RZ6oW04LHcPob9dGOi2sN6Hcq2ZSsWwYR6iry8MX4Pw_XWUMerTFVW1s2X8EwAeAKl-Tojb3GjESc4jEIUSihEjMIRKzOa8fmnOP-JMa8hvjuMNy</recordid><startdate>20151208</startdate><enddate>20151208</enddate><creator>Lincoln, Nadina B</creator><creator>das Nair, Roshan</creator><creator>Bradshaw, Lucy</creator><creator>Constantinescu, Cris S</creator><creator>Drummond, Avril E R</creator><creator>Erven, Alexandra</creator><creator>Evans, Amy L</creator><creator>Fitzsimmons, Deborah</creator><creator>Montgomery, Alan A</creator><creator>Morgan, Miriam</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-5604-2339</orcidid></search><sort><creationdate>20151208</creationdate><title>Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS)</title><author>Lincoln, Nadina B ; das Nair, Roshan ; Bradshaw, Lucy ; Constantinescu, Cris S ; Drummond, Avril E R ; Erven, Alexandra ; Evans, Amy L ; Fitzsimmons, Deborah ; Montgomery, Alan A ; Morgan, Miriam</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c564t-d26796fadc540fc3ab6f8b70a030b8ec66af0d3be8651b99b9209811f96fe9233</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Activities of Daily Living</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Analysis</topic><topic>Attention</topic><topic>Clinical Protocols</topic><topic>Cognition</topic><topic>Cognitive Behavioral Therapy - economics</topic><topic>Cognitive Behavioral Therapy - methods</topic><topic>Cost analysis</topic><topic>Cost control</topic><topic>Cost-Benefit Analysis</topic><topic>Employment</topic><topic>Female</topic><topic>Health aspects</topic><topic>Health Care Costs</topic><topic>Health surveys</topic><topic>Humans</topic><topic>Informed consent</topic><topic>Intention to Treat Analysis</topic><topic>Intervention</topic><topic>Male</topic><topic>Memory</topic><topic>Middle Aged</topic><topic>Multiple sclerosis</topic><topic>Multiple Sclerosis - diagnosis</topic><topic>Multiple Sclerosis - economics</topic><topic>Multiple Sclerosis - psychology</topic><topic>Multiple Sclerosis - rehabilitation</topic><topic>Neuropsychology</topic><topic>Psychiatric Status Rating Scales</topic><topic>Psychologists</topic><topic>Psychotherapy, Group - economics</topic><topic>Psychotherapy, Group - methods</topic><topic>Quality of Life</topic><topic>Questionnaires</topic><topic>Regression Analysis</topic><topic>Rehabilitation</topic><topic>Research Design</topic><topic>Social services</topic><topic>Study Protocol</topic><topic>Surveys and Questionnaires</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>United Kingdom</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lincoln, Nadina B</creatorcontrib><creatorcontrib>das Nair, Roshan</creatorcontrib><creatorcontrib>Bradshaw, Lucy</creatorcontrib><creatorcontrib>Constantinescu, Cris S</creatorcontrib><creatorcontrib>Drummond, Avril E R</creatorcontrib><creatorcontrib>Erven, Alexandra</creatorcontrib><creatorcontrib>Evans, Amy L</creatorcontrib><creatorcontrib>Fitzsimmons, Deborah</creatorcontrib><creatorcontrib>Montgomery, Alan A</creatorcontrib><creatorcontrib>Morgan, Miriam</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lincoln, Nadina B</au><au>das Nair, Roshan</au><au>Bradshaw, Lucy</au><au>Constantinescu, Cris S</au><au>Drummond, Avril E R</au><au>Erven, Alexandra</au><au>Evans, Amy L</au><au>Fitzsimmons, Deborah</au><au>Montgomery, Alan A</au><au>Morgan, Miriam</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS)</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><addtitle>Trials</addtitle><date>2015-12-08</date><risdate>2015</risdate><volume>16</volume><issue>1</issue><spage>556</spage><epage>556</epage><pages>556-556</pages><artnum>556</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual's memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope with these problems, in order to reduce the impact on everyday life. The effectiveness of cognitive rehabilitation for people with multiple sclerosis has not been established.
This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems. All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological subscale at 12 months will be used to estimate the effect of the group cognitive rehabilitation programme.
The study will provide evidence regarding the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems in people with multiple sclerosis.
ISRCTN09697576 . Registered 14 August 2014.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>26643818</pmid><doi>10.1186/s13063-015-1016-3</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-5604-2339</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Current controlled trials in cardiovascular medicine, 2015-12, Vol.16 (1), p.556-556, Article 556 |
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| language | eng |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central; SpringerLink Journals - AutoHoldings; PubMed Central Open Access; Springer Nature OA Free Journals |
| subjects | Activities of Daily Living Adolescent Adult Aged Analysis Attention Clinical Protocols Cognition Cognitive Behavioral Therapy - economics Cognitive Behavioral Therapy - methods Cost analysis Cost control Cost-Benefit Analysis Employment Female Health aspects Health Care Costs Health surveys Humans Informed consent Intention to Treat Analysis Intervention Male Memory Middle Aged Multiple sclerosis Multiple Sclerosis - diagnosis Multiple Sclerosis - economics Multiple Sclerosis - psychology Multiple Sclerosis - rehabilitation Neuropsychology Psychiatric Status Rating Scales Psychologists Psychotherapy, Group - economics Psychotherapy, Group - methods Quality of Life Questionnaires Regression Analysis Rehabilitation Research Design Social services Study Protocol Surveys and Questionnaires Time Factors Treatment Outcome United Kingdom Young Adult |
| title | Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS) |
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